The invention relates to an assaying system. More particularly, the invention relates to an assaying device and container for analyzing a specimen of body fluid to detect the absence of particular substances therein, said assaying device employing a positive control, a negative control, and adulteration test. More specifically, the invention relates to an assaying system employing a test card having assaying means such as chromatograph strips located thereupon, the assaying means having a built-in positive control. Furthermore, adulteration means are also employed by the assaying device to ensure the integrity of the specimen of body fluid collected in the container.
The increase in drug use over the past several decades has created a sharp need for more effective, expeditious methods of analyzing whether a particular individual is a user of certain illegal substances. Both private industry employers as well as governmental employers often need to determine whether an individual has drug residue present in his or her biological system, and hence determine whether such an individual is a drug user or drug abuser and thus an undesirable employee.
Typically, the status of an individual as a drug user or abuser is determined by analysis of the individual's physiological fluids, namely urine. A specimen of urine is collected, and an initial screening test is first performed, usually at a centralized laboratory. If specimen samples screen positive at the central laboratory, then a more sensitive and controlled confirmation analysis must be performed and reviewed by a certified "medical review office" where licensed physicians must confirm the positive results detected by the central laboratory.
In addition to being an extremely costly process, the above mentioned procedure also involves great time delays to employers desirous of obtaining new qualified employees. Upon collection of the urine sample, the employer must wait to receive test results from the central laboratory before hiring any potential employees. Furthermore, the massive amount of handling and transfer of the sample of urine from the initial collection site to the central laboratory and then possibly to a medical review office increases the possibility of contamination and mis-identification of the specimen, and raises various chain of custody problems.
To combat the above mentioned timeliness problem which faces many employers in awaiting results from the central laboratory, various "on-site" or "hand-held" assaying devices have been developed. A major problem inherent in these "on-site" testing devices is that the privacy concerns of the potential employee being tested are not adequately addressed. Since all of the on-site testing devices available heretofore attempt merely to identify drugs present (i.e. simply to indicate which specimens do indeed possess the prohibited substance/drug), the anonymity of a presumptive positive donor is impossible to conceal. Since the definitive positive test results must be determined by a certified laboratory, all "on-site" information utilizing current devices would carry a certain amount of stigma associated with a positive test. The positive donor's status can also be inferred by others due to the fact that his or her employment application is immediately handled differently than those donors who do not test "positively". Due to such lack of anonymity, many employers (governmental in particular) will not employ such an assaying system as it does not comply with federally mandated regulations regarding privacy and civil liberties during drug-employment testing. A more anonymous, reliable and expeditious assaying system is needed, wherein negative results can be obtained quickly without compromising the privacy concerns of the tested individual.
Assaying systems, such as the types discussed above, often tend to lack proper collection and storage means. Commonly, a specimen of physiological fluid such as urine is gathered and stored in one type of collection unit, and then the assaying means are either introduced into the collection unit, or a small volume of the urine specimen is removed from the collection unit and placed upon the assaying device. The various transfers of fluid samples pose a great threat of contamination of the sample, as well as mis-identification. A system which allows collection and assaying of a specimen within one unit would lessen these risks.
Many assaying systems available on the market attempt to ensure the quality and reliability of each individual test by employing a "negative control" to inform the user that the reagents or antibodies used as the assaying means are functioning properly. A signal from the negative control informs the user/administrator of the test that the assaying means have not been compromised. Failure to receive an indication from the negative control can indicate that the integrity of the test has been impinged due to improper storage or handling, and that the assaying unit should be discarded. While this negative control does allow for quality control of the integrity of the diagnostic assay means, it in no way provides any quality control assurances regarding the integrity of the specimen collected. Due to civil liberty concerns, specimen donors are usually permitted a great amount of privacy when providing the specimen. The potential for tampering with the specimen is great, and is in no way addressed by the negative control assurances which deal only with the integrity of the assay means itself. An assaying system possessing some sort of adulteration detecting means is needed in the art to ensure the integrity of the specimen being analyzed.
Assaying systems available on the market attempt to identify the presence of illicit drugs by labeling each assay and making no provisions for the inherent unreliability due to cross reactivity of on site devices. A device which incorporates no assay labels as well as a 5% to 10% positive control would ensure that 90% of the tested population could be immediately available for "hire" or "return to work", while 10% of those tested would require additional central laboratory testing. By including a 5% to 10% positive control, no on-site employer could determine from the results of the on-site test whether the donor was truly positive or simply utilized a control positive collection device.
Accordingly, various types of assaying systems are found in the art, each one lacking one or more much needed traits. For instance, U.S. Pat. No. 4,992,296 to Gibson and 5,356,782 to Moorman et al. are typical references found in the art. While these units may be suitable for the particular purpose employed, or for general use, they would not be as suitable for the purposes of the present invention as disclosed hereafter.